FDA Approves New and Updated Indications for Temozolomide Under Project Renewal
On September 14, 2023, the Food and Drug Administration (FDA) approved updated labeling for temozolomide (Temodar, Merck) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for older... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 14, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Aphexda (motixafortide) to Mobilize Hematopoietic Stem Cells for Autologous Transplantation in Patients with Multiple Myeloma
Aphexda is the first innovation in stem cell mobilization for multiple myeloma to be approved in the U.S. in a decade
One dosage of Aphexda plus filgrastim enabled a majority of patients to achieve the collection goal of≥ 6 million... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 11, 2023 Category: Drugs & Pharmacology Source Type: news
Pfizer and BioNTech Receive U.S. FDA Approval for 2023-2024 COVID-19 Vaccine
This season’s vaccine is tailored to the SARS-CoV-2 XBB.1.5 sublineage and indicated as a single dose for most individuals 5 years of age and older
Pre-clinical data show that the updated COVID-19 vaccine generates improved neutralizing... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 11, 2023 Category: Drugs & Pharmacology Source Type: news
Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccine
Clinical data show robust immune responses across multiple circulating variants, including EG.5, FL.1.5.1, and BA.2.86
Updated vaccine to be available in pharmacies and care settings across the U.S. in the coming days
CAMBRIDGE, MA /... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 11, 2023 Category: Drugs & Pharmacology Source Type: news
U.S. FDA Approves Bristol Myers Squibb ’s Reblozyl (luspatercept-aamt) as First-Line Treatment of Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS) Who May Require Transfusions
PRINCETON, N.J.--(BUSINESS WIRE) August 28, 2023-- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Reblozyl (luspatercept-aamt) for the treatment of anemia without previous... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 28, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Veklury (remdesivir) to Treat COVID-19 in People With Mild to Severe Hepatic Impairment With no Dose Adjustment
FOSTER CITY, Calif.--(BUSINESS WIRE) August 24, 2023 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for the use of Veklury®... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 24, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Tyruko (natalizumab-sztn), a Biosimilar to Tysabri
August 24, 2023 -- The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). Tyruko, like... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 24, 2023 Category: Drugs & Pharmacology Source Type: news
U.S. FDA Approves Abrysvo, Pfizer ’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Infants Through Active Immunization of Pregnant Individuals 32-36 Weeks of Gestational Age
NEW YORK--(BUSINESS WIRE) August 21, 2023 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Abrysvo™ (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 21, 2023 Category: Drugs & Pharmacology Source Type: news
Neurocrine Biosciences Announces FDA Approval of Ingrezza (valbenazine) Capsules for the Treatment of Chorea Associated With Huntington's Disease
SAN DIEGO, Aug. 18, 2023 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration (FDA) has approved Ingrezza® (valbenazine) capsules for the treatment of adults with chorea associated... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 18, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Eylea HD (aflibercept) Injection 8 mg for Treatment of Wet Age-related Macular Degeneration (wAMD), Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR)
TARRYTOWN, N.Y., Aug. 18, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Eylea HD (aflibercept) Injection 8 mg for the treatment of patients with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 18, 2023 Category: Drugs & Pharmacology Source Type: news
Eylea HD (aflibercept) Injection 8 mg Approved by FDA for Treatment of Wet Age-related Macular Degeneration (wAMD), Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR)
TARRYTOWN, N.Y., Aug. 18, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Eylea HD (aflibercept) Injection 8 mg for the treatment of patients with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 18, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Veopoz (pozelimab-bbfg) as the First Treatment for Children and Adults with CHAPLE Disease
TARRYTOWN, N.Y., Aug. 18, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has approved Veopoz™ (pozelimab-bbfg) for the treatment of adult and pediatric... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 18, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Sohonos (palovarotene) for the Treatment of Fibrodysplasia Ossificans Progressiva
PARIS, FRANCE, 16 August 2023– Ipsen (Euronext: IPN; ADR: IPSEY) announced today approval by the U.S. Food and Drug Administration (FDA) of Sohonos™ (palovarotene) capsules as a retinoid indicated for the reduction in volume of new... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 16, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves First Therapeutic Indication for Revance ’s Daxxify (daxibotulinumtoxinA-lanm) for Injection for the Treatment of Cervical Dystonia
Provides Revance entry into the $2.5 billion U.S. therapeutic neuromodulator market.1
Approval expands the Daxxify® label to include efficacy data over the 52-week ASPEN repeat dose clinical study.
Daxxify® for cervical dystonia is the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 15, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Grants Accelerated Approval for Elrexfio (elranatamab-bcmm) for Relapsed or Refractory Multiple Myeloma
The approval of Elrexfio (elranatamab-bcmm) is based on clinically meaningful response rates and duration of response from Phase 2 MagnetisMM-3 study
Elrexfio is the first off-the-shelf (ready-to-use) fixed-dose subcutaneous BCMA-directed agent... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 14, 2023 Category: Drugs & Pharmacology Source Type: news
